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510(k) K132276

Device
STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML
Applicant
HOSPIRA, INC.
510(k) number
K132276
Product code
KPE  
Decision
Substantially Equivalent (SESE)
Decision date
2013-11-12
Date received
2013-07-22
Regulation
880.5025
Classification name
Container, I.v.
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ABIGAIL FERGUSON
Address
275 N. Field Dr. Lake Forest IL US 60045 60045

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KPE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252079Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd.2026-04-02
K251980ClaveQS™ BagIcu Medical, Inc.2026-03-20
K251139KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AG2026-01-09
K252094eZSURE™ Empty Fluid ContainerEpic Medical Pte. , Ltd.2025-08-01
K250459DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container SolutionTechnoflex Sas.2025-04-18
K241442eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteEpic Medical Pte. , Ltd.2024-06-21
K223674eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)Epic Medical Pte. , Ltd.2023-09-01
K222622Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd.2023-02-16
K210749Empty EVA BagHaemotronic S.P.A.2021-08-19
K201936SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mLGilero, LLC2021-05-06
K193528Empty EVA BagHaemotronic S.P.A.2020-07-22
K190328HCT Empty EVA Container PackHealth Care Technologies2019-08-15
K190305Additive CapInternational Medical Industries, Inc.2019-04-30
K181393Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BPValmed S.R.L.2019-02-15
K121161EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINERActa Medical, LLC2012-07-13

Legacy Summary#

summary

FDA Review#

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